gastric cancer
Conditions
Interventions
irinotecan/ramucirumab CPT-11:level1 150mg/m2,q2w, level0 120mg/m2,q2w, level-1 100mg/m2,q2w Rumucirumab:8mg/kg,q2w until evidence of progressin, unacceptable toxicity, or patinet refusal
Sponsors
Kobe City Medical Center General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histlogically proven gastric adenocarcinoma (including adenocarcinoma of the GEJ) 2) previously teated with fluoropyrimigine with/without platinum and taxane 3) with target lesion(RECIST version1.1) 4) Performance status must be Eastern Cooperative Oncology Group (ECOG) 0, or 1 4) Age >= 20 years 5) Adequate bone marrow, hepatic, renal, cardiac and respiratory functions 7) Written informed consent
Exclusion criteria
Exclusion criteria: 1) active synchronous or metachronous malignancy 2) previously treated with irinotecan 3) uncontrolled hypertension 4) active infection 5) serious coexisting illness 6) intensive surgery within 28 days prior to the registration 7) embolism and thrombosis, or grade 3 or more GI bleeding within 3 months prior to the registration 8) uncontrolled diarrhea 9) severe allergy 10) moderate or more pleural effusion/ascites 11) systemic steroid user 12) severe mental disorders 13) symptomatic central metastasis 14) atazanavir user 15) pregnant or nursing 16) active hepatitis 17) UGT1A1*6/*6, *28/*28, *6/*28 18) other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety DLT DLTobservation period=first course | — |
Countries
Japan
Contacts
Public ContactHironaga Satake
Kobe City Medical Center General Hospital Department of Medical Oncology
Outcome results
None listed